MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK F/G WINGSPAN STENT SYSTEM 3.0 X 15MM; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number M003WE0300150

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the proximal end of the stabilizer/ hub was kinked and fractured, the stent was partially deployed from the delivery catheter and the delivery catheter shaft was noted to be flattened along the entire shaft length.Functional testing revealed that the delivery catheter was flushed, and the stabilizer was advanced to deploy the stent without difficulty.There were no anomalies noted to the deployed stent.The distal tapered tip was cut in order to remove the stabilizer, the stabilizer was removed from the catheter without difficulty.There were no further anomalies noted to the stabilizer.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event was confirmed.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.

Event Description

Analysis of the returned device found the stent was partially deployed and the proximal end of the stabilizer was broken from the device.There were no clinical consequences to the patient.

• Brand Name: F/G WINGSPAN STENT SYSTEM 3.0 X 15MM
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9596624
• MDR Text Key: 176664304
• Report Number: 3008881809-2020-00007
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Catalogue Number: M003WE0300150
• Device Lot Number: 21264353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1